CN214388486U - Sensor assembly and sensor - Google Patents

Sensor assembly and sensor Download PDF

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Publication number
CN214388486U
CN214388486U CN202022287112.3U CN202022287112U CN214388486U CN 214388486 U CN214388486 U CN 214388486U CN 202022287112 U CN202022287112 U CN 202022287112U CN 214388486 U CN214388486 U CN 214388486U
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sensor
elongate
elongated
infusion site
catheter infusion
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Chinese (zh)
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杨志明
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Becton Dickinson and Co
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Becton Dickinson and Co
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683Means for maintaining contact with the body
    • A61B5/6832Means for maintaining contact with the body using adhesives
    • A61B5/68335Means for maintaining contact with the body using adhesives including release sheets or liners
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/02Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/02042Determining blood loss or bleeding, e.g. during a surgical procedure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/103Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/107Measuring physical dimensions, e.g. size of the entire body or parts thereof
    • A61B5/1077Measuring of profiles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/48Other medical applications
    • A61B5/4869Determining body composition
    • A61B5/4875Hydration status, fluid retention of the body
    • A61B5/4878Evaluating oedema
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06Body-piercing guide needles or the like
    • A61M25/0606"Over-the-needle" catheter assemblies, e.g. I.V. catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16831Monitoring, detecting, signalling or eliminating infusion flow anomalies
    • A61M5/16836Monitoring, detecting, signalling or eliminating infusion flow anomalies by sensing tissue properties at the infusion site, e.g. for detecting infiltration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0261Strain gauges
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3306Optical measuring means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/60General characteristics of the apparatus with identification means
    • A61M2205/6063Optical identification systems
    • A61M2205/6081Colour codes

Abstract

The present disclosure relates to a sensor assembly and a sensor. It is an object of one aspect of the present disclosure to provide a sensor. The sensor may include: a first elongate sensor member coupleable to a first location adjacent a catheter infusion site; and a second elongate sensor member coupleable to a second location adjacent the catheter infusion site. The first elongate sensor member includes a first marker and the second elongate sensor member includes a second marker. The first elongate sensor member is slidably coupled with the second elongate sensor and translates relative to the second elongate sensor. The first and second indicia indicate a range of relative positions between the first and second elongated sensor members as the first and second elongated sensor members translate relative to each other. A technical effect of one aspect of the present disclosure is to provide a sensor.

Description

Sensor assembly and sensor
Technical Field
The present disclosure relates to the field of infusion, and more particularly, to sensors.
Background
Catheters are commonly used for a variety of infusion therapies. For example, catheters may be used to infuse fluids into a patient, such as saline solutions, drugs, parenteral nutrition, and the like. Catheters may also be used to draw blood from a patient.
A common type of catheter is an over-the-needle (over-the-needle) peripheral intravenous catheter ("PIVC"). As the name suggests, the over-the-needle PIVC can be mounted on a puncture needle having a sharp distal tip. The PIVC and the introducer needle can be assembled such that the distal tip of the introducer needle extends beyond the distal tip of the PIVC and the bevel of the needle faces away from the patient's skin. PIVCs and puncture needles are typically inserted through the skin at a shallow angle and into a patient's blood vessel, such as a patient's artery, vein, or any other vasculature of the patient. Once the PIVC is properly positioned within the blood vessel, the puncture needle can be withdrawn and the PIVC can be secured within the blood vessel by securing the catheter adapter (coupled with the PIVC) to the patient's skin with the dressing. Other common types of catheters include, but are not limited to, peripherally inserted central catheters ("PICC"), central venous catheters ("CVC"), and the like.
Unfortunately, fluid delivered to a patient through a catheter sometimes leaks into the tissue surrounding the catheter infusion site. The penetration of fluids into these tissues may be due to: (1) the catheter is initially improperly placed; (2) the catheter is then removed from the blood vessel; (3) the catheter fluid extravasates into the surrounding tissue, etc.
Thus, improved sensors and methods for detecting fluid infiltration at a catheter infusion site are desired. For example, improved sensors and methods for detecting fluid infiltration may help clinicians quickly identify when an infiltration event occurs. The clinician can then immediately take corrective action to address the infiltration event, such as: (1) preventing further penetration from occurring; (2) raising the infiltration site to reduce swelling; (3) applying hot or cold pressure (depending on the fluid) to the infiltration site to help reduce swelling and/or discomfort; (4) treating the patient with any appropriate drug(s) that may be needed, and so forth.
The subject matter claimed herein is not limited to embodiments that solve any disadvantages noted above or that operate only in the environments noted above. Rather, this background is provided only to illustrate one example area of technology in which some embodiments described herein may be practiced.
SUMMERY OF THE UTILITY MODEL
The present disclosure relates generally to sensors and methods for detecting fluid infiltration at a catheter infusion site of a patient. The various sensors and methods of the present disclosure have been developed in response to the present state of the art, and in particular, in response to the problems and needs in the art that have not yet been fully solved by currently available sensors and methods for detecting fluid infiltration at a catheter infusion site of a patient.
It is an object of one aspect of the present disclosure to provide a sensor.
In some embodiments, a sensor assembly for detecting fluid infiltration at a catheter infusion site of a patient may generally include a first elongate sensor, a second elongate sensor, a first marker, and a second marker. The first elongate sensor member may be configured to be coupled to a patient at a first location adjacent a catheter infusion site. The second elongate sensor member may be configured to be coupled to the patient at a second location adjacent to the catheter infusion site. The second elongate sensor member may comprise a housing (envelope) comprising a lower elongate member and an upper elongate member. The upper elongated member may be coupled to the lower elongated member, defining an interior space between the lower elongated member and the upper elongated member. The interior space of the housing may be configured to receive the first elongate sensor member therein, and the open end of the housing may be configured to allow the first end of the first elongate sensor member to protrude from the open end of the housing. The first marker may be coupled to the first elongated sensor member and the second marker may be coupled to the upper elongated member of the second elongated sensor member. The first elongate sensor member may be slidably coupled within the second elongate sensor member such that the first and second elongate sensor members are translatable relative to each other. The first and second indicia may be configured to indicate a range of relative positions between the first and second elongate sensor members as the first and second elongate sensor members translate relative to one another. At least one relative position within the range of relative positions between the first and second elongate sensor members may be indicative of infiltration at the catheter infusion site.
In some embodiments of the sensor assembly, the first indicia may comprise a first shape having a first color and a first size, and the second indicia may comprise a second shape having a second color and a second size.
In some embodiments of the sensor assembly, the first and second shapes and the first and second dimensions may be substantially similar to each other, and the first and second colors may be different from each other. Thus, in the first position, the first indicia may visually obscure the second indicia, and in the second position, the first indicia may visually obscure at least a portion of the second indicia to indicate that infiltration of the catheter infusion site has occurred.
In some embodiments, the sensor assembly may further include a light sensor configured to detect at least one of the first color and the second color.
In some embodiments of the sensor assembly, the first adhesive member may be configured to couple the first elongate sensor member to the patient at a first location adjacent the catheter infusion site, and the second adhesive member may be configured to couple the lower elongate member of the second elongate sensor member to the patient at a second location adjacent the catheter infusion site.
In some embodiments of the sensor assembly, the removable lower cover may be configured to protect the first and second adhesive members, and the removable upper cover may be configured to maintain the relative position between the first and second elongate sensor members.
In some embodiments, the sensor assembly may also be an anti-stiction component configured to reduce friction between the first and second elongated sensor members.
In some embodiments, a sensor for detecting infiltration at a catheter infusion site may include: a first elongate sensor member configured to be coupled to a patient at a first location adjacent a catheter infusion site; a second elongate sensor member configured to be coupled to the patient at a second location adjacent the catheter infusion site; at least one first marker coupled to the first elongated sensor member; and at least one second marker coupled to the second elongated sensor member. The first elongate sensor member may be slidably coupled to the second elongate sensor member such that the first and second elongate sensor members are translatable relative to each other. The at least one first and second indicia may be configured to indicate a range of relative positions between the first and second elongate sensor members as the first and second elongate sensor members translate relative to one another. At least one relative position within the range of relative positions between the first and second elongate sensor members may be indicative of infiltration at the catheter infusion site.
In some embodiments of the sensor, the at least one first marker may comprise a first shape having a first color and a first size, and the at least one second marker may comprise a second shape having a second color and a second size.
In some embodiments of the sensor, the first and second shapes and the first and second dimensions may be substantially similar to each other, and the first and second colors may be different from each other. Thus, in the first position, the at least one first indicia may visually obscure the at least one second indicia, and in the second position, the at least one first indicia may not visually obscure at least a portion of the at least one second indicia to indicate that an osmotic event at the catheter infusion site has occurred.
In some embodiments of the sensor, the second elongated sensor member may comprise a housing. The housing may include a lower elongated member and an upper elongated member coupled to the lower elongated member to define an interior space between the lower and upper elongated members. The interior space of the housing may be configured to receive the first elongated sensor member therein. The open end of the housing may be configured to allow the first end of the first elongate sensor member to protrude from the open end of the housing.
In some embodiments of the sensor, the first adhesive member may be configured to couple the first elongate sensor member to the patient at a first location adjacent the catheter infusion site, and the second adhesive member may be configured to couple the second elongate sensor member to the patient at a second location adjacent the catheter infusion site.
In some embodiments of the sensor, the removable lower cover may be configured to protect the first and second adhesive members, and the removable upper cover may be configured to maintain the relative position between the first and second elongate sensor members.
In some embodiments, the sensor may further comprise an anti-stiction component configured to reduce friction between the first and second elongate sensor members.
In some embodiments, a method for detecting fluid infiltration at a catheter infusion site of a patient with a sensor may include: the method includes applying a first elongate sensor member to a first location adjacent a catheter infusion site, and applying a second elongate sensor member to a second location adjacent the catheter infusion site. The method may further comprise checking the sensor after it has been applied to the patient to ensure that the first indicia of the first elongate sensor member is covered by the second indicia of the second elongate sensor member. The method may further include monitoring the sensor to detect subsequent infiltration at the catheter infusion site of the patient. The first elongate sensor member may be slidably coupled to the second elongate sensor member such that the first and second elongate sensor members are translatable relative to each other. The first and second indicia may be configured to indicate a range of relative positions between the first and second elongate sensor members as the first and second elongate sensor members translate relative to one another. At least one relative position within the range of relative positions between the first and second elongate sensor members may be indicative of infiltration at the catheter infusion site.
In some embodiments of the method, the sensor may further comprise a first adhesive member and a second adhesive member. Applying the sensor at the catheter infusion site of the patient may additionally include applying pressure to the first adhesive member to couple the first elongate sensor member to the patient at the first location and applying pressure to the second adhesive member to couple the second elongate sensor member to the patient at the second location.
In some embodiments, the method may further include removing a removable lower cover configured to protect the first and second adhesive members of the sensor, applying the sensor to a catheter infusion site of a patient, and removing a removable upper cover from the sensor to allow the first and second elongate sensor members to translate relative to each other.
In some embodiments of the method, monitoring the sensor to detect subsequent infiltration at the catheter infusion site may include visually detecting a color associated with at least one of the first and second markers.
In some embodiments of the method, monitoring the sensor to detect subsequent infiltration at the catheter infusion site may include electronically detecting, via the light sensor, a color associated with at least one of the first and second markers.
In some embodiments of the method, monitoring the sensor to detect subsequent infiltration at the catheter infusion site may include measuring a distance between the first marker and the second marker.
A technical effect of one aspect of the present disclosure is to provide a sensor.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are not restrictive of the embodiments of the disclosure, as claimed. It should be understood that the various embodiments of the disclosure are not limited to the arrangements and instrumentality shown in the attached drawings. It is also to be understood that the embodiments of the disclosure may be combined, or other embodiments may be utilized, and structural changes may be made, unless so required, without departing from the spirit or scope of the various embodiments of the disclosure. The following detailed description is, therefore, not to be taken in a limiting sense.
Drawings
Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
FIG. 1 is an exploded view of a sensor configured to detect fluid infiltration at a catheter infusion site of a patient, according to some embodiments;
FIG. 2 illustrates the sensor of FIG. 1 assembled together and applied near a catheter infusion site of a patient prior to an osmotic event;
FIG. 3 illustrates the sensor of FIG. 2 after a permeation event has occurred; and
FIG. 4 is a flow chart of a method for detecting fluid infiltration at a catheter infusion site of a patient.
It is to be understood that the drawings are for purposes of illustrating the concepts of the disclosure and may not be to scale. Furthermore, the drawings illustrate exemplary embodiments and do not represent limitations on the scope of the disclosure.
Detailed Description
Exemplary embodiments of the present disclosure will be best understood by reference to the drawings, wherein like parts are designated by like numerals throughout. It will be readily understood that the components of the present disclosure, as generally described and illustrated in the figures herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of the embodiments of the apparatus and system, as represented in the figures, is not intended to limit the scope of the disclosure, as claimed in this application or any other application claiming priority thereto, but is merely representative of exemplary embodiments of the disclosure.
Fig. 1-3 illustrate various views of a sensor assembly (or sensor 100) for detecting fluid infiltration at a catheter infusion site 210 of a patient, according to some embodiments. Specifically, FIG. 1 illustrates an exploded view of sensor 100; fig. 2 illustrates the sensor 100 assembled together and coupled to a patient adjacent a catheter infusion site 210 prior to an osmotic event occurring at the catheter infusion site 210; and fig. 3 illustrates the sensor 100 after an osmotic event has occurred at the catheter infusion site 210. For example, note that the patient's hand 200 is shown slightly enlarged or "bulged" in FIG. 3 due to fluid penetration into the patient's hand 200. When this occurs, the surface distance between the two fixed points on the patient's hand 200 will increase near the catheter infusion site. The sensor(s) disclosed herein are designed to sense and indicate such an increase in surface distance. For purposes of illustration only in this disclosure, only the catheter infusion site 210 on the patient (e.g., on the patient's hand 200) is selected as one example catheter infusion site on the patient. Thus, it will be understood that any of the sensor(s) and/or method(s) described herein may be used at any desired catheter infusion site on a patient.
In general, the sensor 100 may include a first elongated sensor member 110, a second elongated sensor member 120, a first marker 131, and a second marker 132.
In some embodiments, the first elongate sensor member 110 can be configured to be coupled to a patient at a first location 201 adjacent to a catheter infusion site 210 (see, e.g., fig. 2 and 3). In at least one embodiment, the first adhesive member 141 can be used to couple the first elongate sensor member 110 to the patient at a first location 201 adjacent to the catheter infusion site 210. Likewise, the second elongate sensor member 120 can be configured to be coupled to the patient at a second location 202 adjacent to the catheter infusion site 210. In at least one embodiment, the second adhesive member 142 can be used to couple the second elongate sensor member 120 to the patient at the second location 202 adjacent the catheter infusion site 210. Any of the adhesive members described herein may be a double-sided adhesive member and/or a single-sided adhesive member.
In some embodiments, the second elongated sensor member 120 may include a housing. The housing may include a lower elongated member 122 and an upper elongated member 124. The lower and upper elongated members 122, 124 may be coupled to one another along their lengths to define an interior space between the lower and upper elongated members 122, 124. The interior space between the lower elongated member 122 and the upper elongated member 124 may be configured to slidably receive the first elongated sensor member 110 therein. However, one (or both) of the distal ends of the lower and upper elongated members 122, 124 may not be coupled to each other to form one or more open ends in the housing. In this way, the open end of the housing may allow the first end 111 of the first elongate sensor member 110 to protrude from the open end of the housing.
In some embodiments, the first marker 131 can be coupled to the first elongated sensor member 110 and the second marker 132 can be coupled to the upper elongated member 124 of the second elongated sensor member 120.
In some embodiments, at least one of the first mark 131 and the second mark may include a plurality of marks.
In some embodiments, the first indicia may include a first shape (e.g., circular, square, etc.) having a first color (e.g., red, black, etc.) and a first size, while the second indicia may include a second shape (e.g., circular, square, etc.) having a second color (e.g., red, black, etc.) and a second size.
In some embodiments, the first and second shapes and first and second sizes may be substantially similar to each other, and the first and second colors may be different from each other (e.g., in one non-limiting example, the first indicia may be red circles and the second indicia may be black circles having substantially similar sizes).
In some embodiments, the first elongate sensor member 110 can be slidably coupled within the second elongate sensor member 120 such that the first elongate sensor member 110 and the second elongate sensor member 120 can translate relative to one another. The first and second indicia 131, 132 may be configured to indicate a range of relative positions between the first and second elongated sensor members 110, 120 as the first and second elongated sensor members 110, 120 translate relative to each other. At least one relative position within the range of relative positions between the first and second elongated sensor members 110, 120 may be indicative of infiltration at the catheter infusion site. For example, in a first position of the sensor 100 (e.g., before a permeation event occurs), the first marker 131 may be visually obscured by a second marker 132 located directly above the first marker 131 (e.g., see fig. 2). However, in the second position of the sensor 100 (e.g., after a permeation event has occurred), the second marker 132 may not visually obscure at least a portion of the first marker 131 to indicate that a permeation event has occurred at the catheter injection site 210 (e.g., see fig. 3).
In some embodiments, the detection of a permeation event can be accomplished by visually detecting a color (or color change) associated with at least one of the first marker 131 and the second marker 132.
In some embodiments, detection of a permeation event can be achieved by electronically detecting a color (or color change) associated with at least one of the first marker 131 and the second marker 132. This may be accomplished with LEDs and/or light sensors (not shown). The signal generated by the light sensor can then be used to trigger an alarm via any known method in the art (e.g., via a bluetooth signal to a phone, via an electronic signal to a pump to stop further catheter infusion, etc.).
In some embodiments, detection of a permeation event may be achieved by measuring the distance between the first and second markers 131, 132, either visually or electronically (e.g., via a linear encoder, not shown).
In summary, there are many different ways to detect and/or measure translation between the first and second elongate sensor members 110, 120 to identify when a permeation event has occurred, and each of these methods is contemplated and incorporated herein in accordance with the spirit and scope of the present disclosure.
In some embodiments, the sensor 100 may also include a removable lower cover 152. The removable lower cover 152 may be configured to protect the first and second adhesive members 141 and 142 during storage and transportation of the sensor 100 prior to use. In this manner, the clinician may remove the removable lower cap 152 from the sensor 100 and immediately couple the sensor 100 to the patient at the time of catheter infusion to help maximize the "tackiness" of the first and second adhesive members 141, 142.
In some embodiments, the sensor 100 may further include a removable upper cover 154 and/or a third adhesive member 143. The removable cover 154 and/or the third adhesive member 143 may be configured to maintain the relative position between the first and second elongated sensor members 110, 120 during storage and transport of the sensor 100 prior to use. For example, when the sensor 100 is manufactured and assembled, the first marker 131 may be positioned directly below the second marker 132 (e.g., in a first or "start" position of the sensor 100), and then the third adhesive member 143 and/or the removable cover 154 may be applied to the sensor 100 to maintain this first/start position during storage and transport of the sensor 100 prior to use. In this manner, the clinician may remove the removable lower cap 152 from the sensor 100, apply the sensor to the catheter infusion site of the patient, and then remove the removable upper cap 154 (and/or the third adhesive member 143) from the sensor 100 to allow the first and second elongate sensor members 110, 120 to translate relative to each other after the sensor has been coupled to the patient. The sensor 100 is then free to expand and begin the process of monitoring for possible permeation events at the catheter infusion site.
In some embodiments, the sensor 100 may also include an anti-stiction component (not shown). The anti-stiction means may be configured to reduce friction between the first and second elongated sensor members 110, 120 to ensure that the first and second elongated sensor members 110, 120 are free to translate relative to each other. Exemplary anti-blocking components may include, but are not limited to: (1) indentations, recesses, protrusions, patterns, etc. formed on one or both of the first and second elongated sensor members 110, 120 to reduce stiction; (2) a lubricant applied to one or both of the first and second elongate sensor members 110, 120 for reducing static friction; (3) one or more materials incorporated into one or both of the first and second elongated sensor members 110, 120 to reduce stiction, and the like.
In some embodiments, at least some of the components of the sensor 100 may be made of a flexible transparent plastic material to facilitate conformance of the sensor 100 to the catheter infusion site 210 and/or to facilitate visual detection of the first marker 131 by the second elongate sensor member 120. However, it will be understood that any of the components of the sensor 100 may be made of any suitable material.
Fig. 4 illustrates a flow chart of a method 400 for detecting fluid infiltration at a catheter infusion site of a patient with a sensor. The method 400 may begin at step 410, where a removable lower cover may be removed from the sensor. In some embodiments, the removable lower cover may be configured to protect the first adhesive member and the second adhesive member of the sensor.
Once the removable lower cover has been removed from the sensor, the method 400 may proceed to step 420, where the sensor may be applied to a catheter infusion site of the patient.
In some embodiments, the sensor may be applied to a catheter infusion site of a patient by applying a first elongate sensor member to a first location adjacent the catheter infusion site (in step 430) and applying a second elongate sensor member to a second location adjacent the catheter infusion site (in step 440). In certain embodiments, the sensor may be applied to the catheter infusion site of the patient by applying pressure to the first adhesive member to couple the first elongate sensor member to the patient at the first location and applying pressure to the second adhesive member to couple the second elongate sensor member to the patient at the second location (in step 450).
Once the sensor has been applied to the catheter infusion site of the patient, the method 400 may proceed to step 460, where the sensor may be checked (after the sensor has been applied to the patient) to ensure that the first indicia of the first elongate sensor member is covered by the second indicia of the second elongate sensor member. This may be referred to as a "first position" or "start position," which may indicate that an osmotic event has not occurred at the catheter infusion site.
Once the sensor has been inspected to ensure that the first indicia of the first elongate sensor member is covered by the second indicia of the second elongate sensor member, the method 400 may proceed to step 470, where the removable upper cover may be removed from the sensor to allow the first and second elongate sensor members to translate relative to each other.
Once the removable cover has been removed from the sensor to allow the first and second elongate sensor members to translate relative to one another, the method 400 may proceed to step 480, where the sensor may be monitored to detect subsequent infiltration at the catheter infusion site of the patient. The penetration detection may be facilitated by the sensor in view of the following: (1) the first elongate sensor member may be slidably coupled to the second elongate sensor member such that the first and second elongate sensor members are translatable relative to each other; (2) the first and second indicia may be configured to indicate a range of relative positions between the first and second elongate sensor members as the first and second elongate sensor members translate relative to one another; and (3) at least one relative position within the range of relative positions between the first and second elongate sensor members may be indicative of infiltration at the catheter infusion site.
Any method disclosed herein comprises one or more steps or actions for performing the described method. One or more method steps and/or actions may be omitted from any of the methods disclosed herein. Moreover, any method steps and/or actions may be interchanged with one another. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order and/or use of specific steps and/or actions may be modified.
Reference throughout this specification to "an embodiment" or "the embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the phrases referred to, or variations thereof, recited throughout this specification are not necessarily all referring to the same embodiment. It should be understood that any embodiment of the present disclosure or any portion(s) of any embodiment of the present disclosure may be combined together in any number of different ways.
Similarly, it should be appreciated that in the foregoing description of embodiments, various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure. However, the disclosed format should not be interpreted as reflecting an intention to: any claim requires more features than are expressly recited in that claim. Rather, as the following claims reflect, inventive aspects lie in a combination of less than all features of any single foregoing disclosed embodiment. Thus, the claims following this detailed description are hereby expressly incorporated into this detailed description, with each claim standing on its own as a separate embodiment. The present disclosure includes all permutations of the independent claims and their dependent claims.
Recitation in the claims of the term "first" with respect to a feature or element does not necessarily imply the presence of a second or additional such feature or element. Elements recited in the component-plus-function format are intended to be interpreted in accordance with 35u.s.c. § 112 clause 6. It will be clear to a person skilled in the art that changes may be made to the details of the above-described embodiments without departing from the basic principles set forth herein.
Standard medical guidelines, reference planes, and descriptive terminology are used in this specification. For example, forward means toward the front of the body. Posterior means toward the back of the body. Upper means towards the head. Lower means towards the foot. Medial means toward the midline of the body. Lateral means away from the midline of the body. Axial means towards the central axis of the body. The dorsal axis means the central axis away from the body. Ipsilateral means on the same side of the body. Contralateral means on the other side of the body. The sagittal plane divides the body into left and right parts. The sagittal midplane divides the body into left and right halves that are bilaterally symmetric. The coronal plane divides the body into an anterior portion and a posterior portion. The transverse plane divides the body into an upper part and a lower part. These descriptive terms may apply to animate or inanimate bodies.
The phrases "connected to," "coupled to," "engaged with …," and "in communication with …" refer to any form of interaction between two or more entities, including mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interactions. Two components may be functionally coupled to each other even though they are not in direct contact with each other. The term "contiguous" refers to items that are in direct physical contact with each other, but the items do not necessarily have to be attached together. The phrase "in fluid communication" refers to two features being connected such that fluid within one feature is able to enter the other feature.
The word "exemplary" is used herein to mean "serving as an example, instance, or illustration. Any embodiment described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments. While various aspects of the embodiments are presented in drawings, the drawings are not necessarily drawn to scale unless specifically indicated.
As defined herein, "substantially equal" means "equal to" or within about + or-10% relative variance of each other.
While specific embodiments and applications of the present disclosure have been illustrated and described, it is to be understood that the scope of the appended claims is not limited to the precise configuration and components disclosed herein. Various modifications, changes, and variations apparent to those skilled in the art may be made in the arrangement, operation, and details of the devices and systems disclosed herein.
All examples and conditional language recited herein are intended for pedagogical purposes to aid the reader in understanding the concepts contributed by the inventor to furthering the art, and are to be construed as being without limitation to such specifically recited examples and conditions. Although the embodiments of the present disclosure have been described in detail, it should be understood that various changes, substitutions, and alterations can be made hereto without departing from the spirit and scope of the disclosure.

Claims (14)

1. A sensor assembly for detecting fluid infiltration at a catheter infusion site in a patient, the sensor assembly comprising:
a first elongate sensor member configured to be coupled to a patient at a first location adjacent a catheter infusion site;
a second elongate sensor member configured to be coupled to a patient at a second location adjacent to a catheter infusion site, the second elongate sensor member comprising a housing comprising:
a lower elongated member; and
an upper elongated member coupled to the lower elongated member and defining an interior space between the lower elongated member and the upper elongated member,
wherein:
the interior space of the housing is configured to receive a first elongated sensor member therein; and
the open end of the housing is configured to allow the first end of the first elongated sensor member to protrude from the open end of the housing;
a first marker coupled to the first elongate sensor member; and
a second marker coupled to the upper elongated member of the second elongated sensor member;
wherein:
the first elongate sensor member is slidably coupled within the second elongate sensor member such that the first elongate sensor member and the second elongate sensor member are translatable relative to each other;
the first and second indicia are configured to indicate a range of relative positions between the first and second elongate sensor members as the first and second elongate sensor members translate relative to each other; and
at least one relative position within a range of relative positions between the first and second elongate sensor members is indicative of infiltration at the catheter infusion site.
2. The sensor assembly of claim 1, wherein:
the first indicia comprises a first shape having a first color and a first size; and
the second indicia includes a second shape having a second color and a second size.
3. The sensor assembly of claim 2, wherein:
the first and second shapes and the first and second dimensions are substantially similar to each other; and
the first color and the second color are different from each other;
wherein:
in the first position, the second indicia visually obscures the first indicia; and
in the second position, the second marker does not visually obscure at least a portion of the first marker to indicate infiltration at the catheter infusion site.
4. The sensor assembly of claim 2, further comprising a light sensor configured to detect at least one of the first color and the second color.
5. The sensor assembly of claim 1, further comprising:
a first adhesive member configured to couple the first elongate sensor member to the patient at a first location adjacent the catheter infusion site; and
a second adhesive member configured to couple the lower elongate member of the second elongate sensor member to the patient at a second location adjacent the catheter infusion site.
6. The sensor assembly of claim 5, further comprising:
a removable lower cover configured to protect the first adhesive member and the second adhesive member; and
a removable upper cover configured to maintain a relative position between the first and second elongated sensor members.
7. The sensor assembly of claim 1, further comprising an anti-stiction component configured to reduce friction between the first elongated sensor member and the second elongated sensor member.
8. A sensor for detecting infiltration at a catheter infusion site, comprising:
a first elongate sensor member configured to be coupled to a patient at a first location adjacent a catheter infusion site;
a second elongate sensor member configured to be coupled to the patient at a second location adjacent the catheter infusion site;
at least one first marker coupled to the first elongated sensor member; and
at least one second marker coupled to the second elongated sensor member;
wherein:
the first elongate sensor member is slidably coupled to the second elongate sensor member such that the first elongate sensor member and the second elongate sensor member are translatable relative to each other;
the at least one first and second indicia are configured to indicate a range of relative positions between the first and second elongate sensor members as the first and second elongate sensor members translate relative to each other; and
at least one relative position within a range of relative positions between the first and second elongate sensor members is indicative of infiltration at the catheter infusion site.
9. The sensor of claim 8, wherein:
the at least one first indicia comprises a first shape having a first color and a first size; and
the at least one second indicia includes a second shape having a second color and a second size.
10. The sensor of claim 9, wherein:
the first and second shapes and the first and second dimensions are substantially similar to each other; and
the first color and the second color are different from each other;
wherein:
in the first position, the at least one second indicia visually obscures the at least one first indicia; and
in the second position, the at least one second indicia does not visually obscure at least a portion of the at least one first indicia to indicate infiltration at the catheter infusion site.
11. The sensor of claim 8, wherein:
the second elongated sensor member includes a housing comprising:
a lower elongated member; and
an upper elongated member coupled to the lower elongated member and defining an interior space between the lower elongated member and the upper elongated member,
wherein:
the interior space of the housing is configured to receive a first elongated sensor member therein; and
the open end of the housing is configured to allow the first end of the first elongated sensor member to protrude from the open end of the housing.
12. The sensor of claim 11, further comprising:
a first adhesive member configured to couple the first elongate sensor member to the patient at a first location adjacent the catheter infusion site; and
a second adhesive member configured to couple the second elongate sensor member to the patient at a second location adjacent the catheter infusion site.
13. The sensor of claim 12, further comprising:
a removable lower cover configured to protect the first adhesive member and the second adhesive member; and
a removable upper cover configured to maintain a relative position between the first and second elongated sensor members.
14. The sensor of claim 8, further comprising an anti-stiction component configured to reduce friction between the first elongated sensor member and the second elongated sensor member.
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US4213463A (en) * 1978-07-24 1980-07-22 Graphic Controls Corporation Body electrode with indicator to ensure optimal securement
US6432074B1 (en) 1997-05-10 2002-08-13 Smith & Nephew Plc Extension indicators
US7730846B2 (en) 2005-10-05 2010-06-08 Qinetiq Limited Strain-responsive visual indicator
US20180280612A1 (en) * 2017-04-04 2018-10-04 Webb Medical LLC Early warning bandage for intravenous blowout or intravenous infiltration and method of monitoring an intravenous infusion site
AU2018247480A1 (en) 2017-04-04 2019-11-07 Webb Medical LLC Bandage for monitoring swelling at a selected site on the body of a patient and method of monitoring swelling at a selected site on the body of a patient
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CN114599268A (en) 2022-06-07
CA3152924A1 (en) 2021-04-22
KR20220079565A (en) 2022-06-13
AU2020367732A1 (en) 2022-04-14
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